Note: This revised article was originally printed in the August issue of HerbalEGram.
by Mark Blumenthal and Katherine Purcell
On July 18, the US Senate confirmed the appointment of Lester M. Crawford, DVM, PhD, as the new Commissioner of the Food and Drug Administration (FDA). The vote in the Senate was 78 for and 16 against.
Dr. Crawford had already been serving as Acting Commissioner since March 2004 when former FDA Commissioner, Mark B. McClellan, MD, PhD, was appointed to head the federal Centers for Medicare and Medicaid Services. Dr. Crawford also served as FDA’s Deputy Commissioner under Dr. McClellan. In February 2005 President Bush nominated Crawford to run the FDA.
According to his biography on the FDA Web site (http://www.fda.gov/oc/crawford/bio.html), Dr. Crawford had previously served as Chair for the Department of Physiology-Pharmacology at the University of Georgia and as Administrator of the Food Safety and Inspection Service at the US Department of Agriculture. From 1997-2002, he was Director of the Center for Food and Nutrition Policy at Georgetown University and at Virginia Tech, where the agency moved in 2001. The FDA bio stated that Crawford played a major role in establishing mandatory nutrition labeling, forming the World Trade Organization, and controlling chemical and microbiological contaminants in food. He was also an advisor to the World Health Organization of the United Nations for much of his career. Dr. Crawford received his Doctor of Veterinary Medicine (DVM) from Auburn University, his PhD in pharmacology from the University of Georgia, and his Honorary Doctorate (MDV) from Budapest University.
The Confirmation Process
Throughout much of the Bush administration, the FDA has not had a Commissioner. This has led to numerous concerns in Congress and elsewhere that the Agency was not being managed as effectively as possible, especially with respect to drug safety, full regulation of dietary supplements, and other related concerns.
Dr. Crawford’s appointment had been stalled recently due to various political issues. Among these issues were concerns by various Senators over the mounting safety problems related to the FDA’s system for the approval of new drugs, particularly in the wake of the recalling Vioxx® and other COX-2 inhibiting drugs. Another political issue that affected his nomination was the FDA’s possible approval of the Plan B birth control pill. One vocal critic of the Plan B pill was Republican Sen. Charles Grassley of Iowa. According to a Reuter’s article, Grassley said, “During Doctor Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent.”1 Two Democrats, Sen. Hillary Clinton (NY) and Sen. Patty Murray (WA), placed holds on Dr. Crawford’s nomination, demanding that the FDA agree to finalize its decision on over-the-counter availability of the controversial birth control pill. Other complications included the concerns of Sen. Tom Coburn (R-OK) that the FDA had not adequately enforced condom labeling. The senators dropped these holds a few days prior to the confirmation.
Responses to Confirmation
Secretary of Health and Human Services Mike Leavitt was supportive of Dr. Crawford’s nomination. In a press release he said, “Dr. Crawford is a dedicated public servant who has ably led the agency [FDA] over the last year and previously served as Deputy Commissioner. The FDA has a critical role in protecting the nation’s food supply and ensuring the safety of the medicines we take based on the best science available. I look forward to working with Dr. Crawford and FDA as we seek to continue advancing the nation’s health.”2
Commissioner Crawford received support from the Senate leaders of both political parties. Sen. Orrin Hatch (R-UT), a leading champion of the dietary supplement industry, said in a press release, “Dr. Crawford is a demonstrated leader, someone with a strong knowledge of science and an unwavering commitment to promoting and protecting the public health. He will be an outstanding commissioner.”3
Sen. Edward Kennedy (D-MA) said, “As a scientist, he recognizes that science is nothing if it lacks integrity. He understands that science loses its power to heal, to inform, to improve lives if the facts are ignored at the whim of politics. I support his confirmation, and I look forward to working with him in the years ahead.”4
Various consumer groups have expressed mixed opinions on the Crawford confirmation. Michael F. Jacobson, the executive director of The Center for Science in the Public Interest (CSPI), offered his opinion in a statement on the center’s Web site: “The FDA is an agency in crisis, especially on the drug side. We hope that Lester Crawford will be able to rise above corporate pressures and the Administration’s anti-regulatory agenda to make consumers’ health his paramount concern.” He continued, “An effective FDA could save hundreds of thousands of lives by promoting better medical practices and improving the nutritional quality of the food supply. Dr. Crawford’s past service in government and in industry raises questions about his appropriateness to lead the beleaguered agency, but we will wish him much success and seek to work with him if he is confirmed as commissioner,” Jacobson said.5
In general, spokespersons from the dietary supplement industry have strongly supported Crawford’s previous record of increasing FDA’s enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA). They also support his position that DSHEA provides adequate safeguards for the effective monitoring of dietary supplement quality, safety, and benefits.
Loren Israelsen, director of the Utah Natural Products Alliance, a Utah-based group representing over 50 large manufacturers and processors of herbs and dietary supplements, made the following statement: “This should be regarded as good news for the DS industry. Dr. Crawford has, over the years, demonstrated a willingness and a practicality to work together with our industry to resolve DS-related issues. As recently as 10 days ago, I had a meeting with him and found his demeanor, perspectives, and comments helpful. We should now hope for a renewed effort by FDA to seek conclusion of open issues relative to dietary supplements such as GMP regulations, other related quality standards, and a more focused enforcement and compliance program.”6
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